{"abstract":"The Food and Drug Administration (FDA) has determined that SULAR (nisoldipine) extended-release tablets, 10 milligrams (mg), 20 mg, 25.5 mg, 30 mg, and 40 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to approve ANDAs for nisoldipine extended-release tablets, 10 mg, 20 mg, 25.5 mg, 30 mg, and 40 mg, if all other legal and regulatory requirements are met.","action":"Notice.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/2014/08/25/2014-20043.html","cfr_references":[],"citation":"79 FR 50659","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":null,"disposition_notes":null,"docket_ids":["Docket No. FDA-2014-P-0549"],"dockets":[],"document_number":"2014-20043","effective_on":null,"end_page":50660,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2014/08/25/2014-20043.xml","html_url":"https://www.federalregister.gov/documents/2014/08/25/2014-20043/determination-that-sular-nisoldipine-extended-release-tablets-10-milligrams-20-milligrams-255","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2014-20043?publication_date=2014-08-25","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2014-08-25/2014-20043/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":850,"last_updated":"2026-04-05 04:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2014-08-25/pdf/2014-20043.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2014-20043.pdf?1408711804","publication_date":"2014-08-25","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2014/08/25/2014-20043.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2014-P-0549","supporting_documents_count":0,"docket_id":"FDA-2014-P-0549","regulation_id_number":null,"title":"Requests that FDA Make a Determination That Shionogim Inc. has Discontinued the Marketing of SULAR (nisoldipine) Extended Release Tablets, 25.5 mg (Under NDA 20-356) for Reasons Unrelated to Safety or Efficacy-CLOSED","checked_regulationsdotgov_at":"2014-09-14T06:00:19Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":50659,"subtype":null,"title":"Determination That SULAR (Nisoldipine) Extended-Release Tablets, 10 Milligrams, 20 Milligrams, 25.5 Milligrams, 30 Milligrams, and 40 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness","toc_doc":"SULAR (Nisoldipine) Extended-Release Tablets, 10 Milligrams, etc.","toc_subject":"Determinations that Products Were Not Withdrawn from Sale for Reasons of Safety or Effectiveness:","topics":[],"type":"Notice","volume":79}